JPS5941744B2 - Medical product packaging - Google Patents
Medical product packagingInfo
- Publication number
- JPS5941744B2 JPS5941744B2 JP54060346A JP6034679A JPS5941744B2 JP S5941744 B2 JPS5941744 B2 JP S5941744B2 JP 54060346 A JP54060346 A JP 54060346A JP 6034679 A JP6034679 A JP 6034679A JP S5941744 B2 JPS5941744 B2 JP S5941744B2
- Authority
- JP
- Japan
- Prior art keywords
- package
- water
- sterilization
- medical article
- moisture
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
Links
Description
【発明の詳細な説明】
この発明はオートクレーブ滅菌等の熱滅菌に適した医療
用物品の包装体に関する。DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a package for medical articles suitable for heat sterilization such as autoclave sterilization.
従来、包装されるべき医療用物品自体が水を含有しない
ものを包装して、オートクレーブ滅菌等により熱滅菌す
る場合、その包装体の少なくとも一部に水蒸気透過性の
良い天然紙あるいは合成紙等を用いたものが使用されて
いた。Conventionally, when packaging medical products that do not contain water themselves and heat sterilizing them by autoclave sterilization, at least a portion of the packaging is made of natural paper or synthetic paper with good water vapor permeability. What was used was used.
しかし、このような従来の包装体は紙材の破損、細菌、
カビ等の発生を防止するため滅菌処理直後に必ず乾燥さ
せなげればならないこと、水蒸気透過性の紙材を使用す
るため、滅菌後も再汚染のおそ世１あると同時に熱滅菌
後に水冷して滅菌処理の迅速化を図ることができないこ
と、被包装体が滅菌処理後も湿気を不可欠とする場合、
水蒸気不透過性の包材でその上にさらに包装する必要が
あることなどの問題があった。However, such conventional packaging is prone to paper material damage, bacteria,
In order to prevent the growth of mold, etc., it must be dried immediately after sterilization, and since water vapor permeable paper is used, there is a risk of re-contamination even after sterilization. If it is not possible to speed up the sterilization process, or if the packaged object requires moisture even after sterilization,
Problems include the need for additional packaging with water vapor impermeable packaging material.
この発明は上記事情に鑑みてなされたものであって、熱
滅菌処理の迅速化を図ることができ、滅菌処理後の再汚
染のおそれがなく、さらに必要に応じ熱滅菌後必要な湿
度を保つことができる医療用物品包装体を提供すること
を目的とする。This invention was made in view of the above circumstances, and can speed up the heat sterilization process, eliminates the risk of re-contamination after the sterilization process, and further maintains the necessary humidity after heat sterilization if necessary. The purpose of the present invention is to provide a medical article packaging body that can
すなわち、この発明は実質的に水蒸気を透過させない可
撓性材料で医療用物品を気密に包装した包装体であって
、熱滅菌時の温度において、該包装体内を飽和蒸気圧以
上に保ち得る量の水分を予め該包装体内に含有させてな
ることを特徴とする医療用物品包装体を提供するもので
ある。That is, the present invention provides a package in which a medical article is airtightly packaged using a flexible material that is substantially impermeable to water vapor, and the package has an amount that can maintain the inside of the package at a saturated vapor pressure or higher at the temperature during heat sterilization. The purpose of the present invention is to provide a medical article packaging body, characterized in that the packaging body contains moisture in advance.
以下、この発明を図示の実施例に基づいて説明する。The present invention will be explained below based on illustrated embodiments.
第１図は本発明に係わる医療用物品包装体の１例を示す
もので、水蒸気を実質的に透過させないプラスチックシ
ート１を２つ折りにし、開口する３辺縁部２をヒートシ
ールし、完全に密閉された袋状に形成されている。FIG. 1 shows an example of a medical article package according to the present invention, in which a plastic sheet 1 that is substantially impermeable to water vapor is folded in half, three open edges 2 are heat-sealed, and the package is completely sealed. It is shaped like a sealed bag.
この場合のプラスチックシート１としては可撓性のプラ
スチックシートであれば特に制限はなく、たとえばポリ
プロピレン、ポリエチレン、ナイロン、ポリエステル、
ポリ塩化ビニル等あるいは他の合成樹脂との積層体から
なり、水蒸気を透過させない実質的に非通気性が得られ
る程度の厚さのものが使用される。The plastic sheet 1 in this case is not particularly limited as long as it is a flexible plastic sheet, such as polypropylene, polyethylene, nylon, polyester, etc.
It is made of a laminate of polyvinyl chloride or other synthetic resins, and has a thickness that does not allow water vapor to pass through and is substantially breathable.
この包装体内部には滅菌処理すべき医療用物品３、たと
えば人工じん臓装置が収容されている。A medical article 3 to be sterilized, for example an artificial kidney device, is accommodated inside this package.
この医療用物品３はそれ自体は実質的に水を含有してい
ない状態で収容され、好ましくは真空包装の状態で収容
される。The medical article 3 itself is accommodated in a substantially water-free state, preferably in a vacuum packaged state.
この包装体内部にはさらに適量の水分を含浸させた吸水
体、例えばろ紙４が収容されている。Inside this package, a water absorbent material, such as filter paper 4, impregnated with an appropriate amount of water is further accommodated.
この場合のろ紙４に含浸させる適量の水分とは熱滅菌処
理時における加熱温度において蒸発して包装体内部を飽
和蒸気圧以上に保持させ得ろ量の水分量、あるいはそれ
以上を云う。In this case, the appropriate amount of water to be impregnated into the filter paper 4 refers to the amount of water that can evaporate at the heating temperature during heat sterilization and maintain the inside of the package at a saturated vapor pressure or higher, or more.
すなわち、その水分量は下記気体状態式によって決定さ
れる。That is, the water content is determined by the following gas state equation.
ＰＶ＝ｎＲＴ
但し、Ｐ：飽和蒸気圧（ａｔｍ 、）
Ｖ：包装体内部空隙＜１＞
ｎ：モル数
Ｒ：気体定数（０，０８２１−ａｔｍ）
Ｔ：絶対温度（２７３＋ｔ’Ｃ）
たとえば、包装体内部空隙が１１であって、これを１１
０℃でオートクレーブ滅菌する場合、包装体内部が真空
になっていると仮定すれば、その必要な水分量は約０．
８１．Ｐ以上となる。PV=nRT However, P: Saturated vapor pressure (atm,) V: Package internal void <1> n: Number of moles R: Gas constant (0,0821-atm) T: Absolute temperature (273+t'C) For example, packaging The internal cavity of the body is 11, and this is 11
When sterilizing in an autoclave at 0°C, assuming that the inside of the package is vacuumed, the required amount of water is approximately 0.
81. It becomes P or more.
第２図に示す実施例は第１図の実施例において、水分導
入媒体としてろ紙４を用いる代りに包装体の一隅角部に
ヒートシール部５を設け、周縁のシール部２との間に水
収容部６を設けたもので、その他の構成は同一であり、
同一の符号が付されている。In the embodiment shown in FIG. 2, instead of using the filter paper 4 as the moisture introduction medium in the embodiment shown in FIG. A storage section 6 is provided, and the other configurations are the same.
The same reference numerals are given.
この第２図に示す実施例の場合、熱滅菌処理後、分散し
た水を遠心分離あるいはその他の適当な方法によって、
再び水収容部６へ集め、その開口部７をヒートシールし
て封鎖し、必要によって、この水収容部６を切り取るよ
うにしてもよい。In the case of the embodiment shown in FIG. 2, after heat sterilization, the dispersed water is centrifuged or by any other suitable method.
The water may be collected again in the water storage section 6, the opening 7 thereof may be sealed by heat sealing, and the water storage section 6 may be cut out if necessary.
また、本発明において、熱滅菌すべき包装体は上述の如
（真空包装によって包装体内部をできるだけ真空にする
ことが好ましいが、必ずしも、これに限らず、オートク
レーブの操作条件を適当に変えろことによって充分な滅
菌を施すことができる。In addition, in the present invention, the package to be heat sterilized is as described above (although it is preferable to make the inside of the package as vacuum as possible by vacuum packaging, the present invention is not limited to this, and can be carried out by appropriately changing the operating conditions of the autoclave. Sufficient sterilization can be performed.
たとえば、包装体内部に空気が多量に入っている場合に
はオートクレーブの加圧条件を適当に高くすることによ
って包装体の膨張破損を防止することができる。For example, if there is a large amount of air inside the package, expansion and damage of the package can be prevented by appropriately increasing the pressure conditions of the autoclave.
この発明に係わる医療用物品包装体によれば、包装体全
体が水蒸気を実質的に透過させない包装材で構成されて
いるから、オートクレーブ等による熱滅菌後にその包装
体を乾燥させる必要がなく、滅菌処理したのち、直ちに
水冷によって冷却することができ、したがって、滅菌処
理工程の著しい時間的短縮を図ることができる。According to the medical product package according to the present invention, since the entire package is made of a packaging material that does not substantially allow water vapor to pass through, there is no need to dry the package after heat sterilization using an autoclave or the like, and sterilization is possible. After the treatment, it can be immediately cooled with water, and therefore the time required for the sterilization process can be significantly shortened.
さらに、このように包装体全体が水蒸気非透過性となっ
ているため、滅菌後の再汚染のおそれもな（、人工じん
臓装置の如く滅菌後の乾燥が好ましくないものでも、従
来の如（非通気性包材で２重に包装することなく、その
ままの状態で適当な湿度に保持することができる。Furthermore, since the entire package is impermeable to water vapor, there is no risk of re-contamination after sterilization. It is possible to maintain the product as it is at an appropriate humidity without having to double wrap it with air-permeable packaging material.
なお、包装体内部に滅菌インジケータを設け、滅菌状態
を外部から確認するようにすることもできる。Note that a sterilization indicator may be provided inside the package so that the sterilization state can be checked from the outside.
なお、包装体内への適量水分の導入方式としては上記実
施例のほか、単に水分を包装体内へ直接導入する方式な
ど種々の形式のものを適宜採用し得るであろう。In addition to the above-mentioned embodiments, various methods may be used to introduce an appropriate amount of moisture into the package, such as a method in which moisture is simply introduced directly into the package.
要は上述の如く適量の水分が熱滅菌時に存在していれば
よい。The point is that an appropriate amount of moisture should be present during heat sterilization as described above.
実施例
第３図に示す如く水分を含有していない人工じん臓装置
１１およびこれに接続される回路部材１２を水蒸気を実
質的に透過させない軟質塩化ビニル樹脂シートを重合し
、周縁をヒートシールした包装体１３内に真空包装する
とともに、その包装体１３内の空隙容積７００ｃｒＡに
対応して、水０．５６７？を含浸させたろ紙１４を予め
導入させた。Example As shown in FIG. 3, an artificial kidney device 11 that does not contain water and a circuit member 12 connected thereto are packaged by polymerizing a soft vinyl chloride resin sheet that does not substantially allow water vapor to pass through, and heat-sealing the periphery. In addition to vacuum packaging in the package 13, water 0.567? A filter paper 14 impregnated with was introduced in advance.
さらに、指標菌としてバシルスステアロサーモフイルス
ＩＡＭ−１１００１の１種を芽胞の状態で１０５〜１０
６個存在させたスポアーペーパを回路のポンプＡ、ドリ
ップチャンバＢ、除圧モニター用ピローＣ１および圧力
モニター〇の内部にそれぞれ入れ、温度１１０℃、圧力
１．７ ｋｇ／ｃｒｔｉの条件で６０分間オートクレー
ブ滅菌をおこなった。Furthermore, one species of Bacillus stearothermophilus IAM-11001 was used as an indicator bacterium in the form of spores with a concentration of 105 to 100%.
Put the 6 pieces of spore paper into the circuit's pump A, drip chamber B, depressurization monitor pillow C1, and pressure monitor 〇, and sterilize them in an autoclave for 60 minutes at a temperature of 110°C and a pressure of 1.7 kg/crti. was carried out.
滅菌後ＴＳＢ培地で６０℃、１週間培養したが菌の生存
は全く認められなかった。After sterilization, the cells were cultured in TSB medium at 60°C for one week, but no survival of the bacteria was observed.
参考のため、上記実施例において包装体１３内に水を含
浸させたろ紙１４を導入しない以外は全く同様にして、
すなわち、包装体１３内に水分を介在させないドライ方
式で同一条件下でオートクレーブ滅菌したのち、同じ＜
ＴＳＢ培地で６０℃１週間培養したところ、ポンプＡ部
に菌の顕著な生存が認められた。For reference, the same procedure as in the above example was carried out except that the water-impregnated filter paper 14 was not introduced into the package 13.
That is, after sterilizing the package 13 in a dry manner under the same conditions with no moisture, the same <
When cultured in TSB medium at 60°C for one week, significant survival of bacteria was observed in pump A section.
なお、上記実施例および参考例について滅菌時間と生存
菌数との関係を回路の各部について調べへ結果、第４〜
第７図に示すような結果が得られた。In addition, for the above examples and reference examples, the relationship between sterilization time and the number of viable bacteria was investigated for each part of the circuit.
The results shown in FIG. 7 were obtained.
第４図は回路のポンプＡ、第５図はチャンバーＢ、第６
図はピローＣ１第７図は圧力モニター部分のものであっ
て、実線は本発明の実施例の場合、破線は参考例の場合
を示す。Figure 4 shows pump A of the circuit, Figure 5 shows chamber B, and pump 6 of the circuit.
The figure shows the pillow C1. FIG. 7 shows the pressure monitor part, and the solid line shows the case of the embodiment of the present invention, and the broken line shows the case of the reference example.
これら結果から明らかなように、適量の水分を包装体内
に存在させることによって滅菌効果が著るしく促進され
ることが確認された。As is clear from these results, it was confirmed that the sterilization effect is significantly promoted by the presence of an appropriate amount of water in the package.
また、医療用物品は内部に水溶液を充填密封した人工じ
ん臓装置等のものでもよく、この場合は該装置の内部は
加熱された水溶液により滅菌され、その外部は包装体内
に含有される水分により滅菌される。In addition, the medical article may be an artificial kidney device or the like that is filled with an aqueous solution and sealed, and in this case, the inside of the device is sterilized by a heated aqueous solution, and the outside is sterilized by moisture contained in the package. be done.
第１図は本発明に係わる医療用物品包装体の１実施例を
示す包装体平面図、第２図は本発明の他の実施例に係わ
る包装体平向図、第３図は人工じん臓装置を本発明の方
法に従って滅菌する場合の１態様を示す包装体平向図、
第４〜７図は本発明の方式およびドライ方式によって熱
滅菌した場合の効果を比較して示す線図である。
図中１・・・・・・プラスチックシート、２・・・・・
・縁部、３・・・・・・医療用物品、４・・・・・・ろ
紙、５・・・・・・ヒートシール部、６・・・・−・水
収容部、７・・・・・・開口部、１１・・・・・・人工
じん臓装置、１２・−・・・・回路部材、１３・・・・
・・包装体、１４・・・・・・ろ紙、Ａ・・・・・−ポ
ンプ、Ｂ・・・・・・ドリップチャンバー、Ｃ・・・・
・・ビロー、Ｄ・・・・・・圧力モニター。FIG. 1 is a plan view of a package showing one embodiment of a medical article package according to the present invention, FIG. 2 is a plan view of a package according to another embodiment of the present invention, and FIG. 3 is an artificial kidney device. A top view of a package showing one embodiment of sterilizing according to the method of the present invention,
FIGS. 4 to 7 are diagrams comparing and showing the effects of heat sterilization using the method of the present invention and the dry method. In the figure 1...Plastic sheet, 2...
・Edge, 3...Medical article, 4...Filter paper, 5...Heat seal part, 6...--Water storage part, 7... ... opening, 11 ... artificial kidney device, 12 ... circuit member, 13 ...
...Package, 14...Filter paper, A...-Pump, B...Drip chamber, C...
...Bello, D...Pressure monitor.
Claims (1)
物品を気密に包装した包装体であって、熱滅菌時の温度
において、該包装体内を飽和蒸気圧以上に保ち得る量の
水分を予め該包装体内に含有させてなることを特徴とす
る医療用物品包装体。 ２ 包装体内に含有される水分が吸水体によって保持さ
れる特許請求の範囲第１項記載の医療用物品包装体。 ３ 包装体内に含有される水分が包装体内の氷収納部に
よって保持される特許請求の範囲第１項記載の医療用物
品包装体。[Scope of Claims] 1. A package in which a medical article is airtightly packaged using a flexible material that is substantially impermeable to water vapor, and which maintains the inside of the package at a saturated vapor pressure or higher at the temperature during heat sterilization. 1. A package for a medical article, characterized in that the package contains a desired amount of moisture in advance. 2. The medical article package according to claim 1, wherein the water contained within the package is retained by the water absorbent. 3. The medical article package according to claim 1, wherein moisture contained within the package is retained by an ice storage section within the package.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP54060346A JPS5941744B2 (en) | 1979-05-18 | 1979-05-18 | Medical product packaging |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP54060346A JPS5941744B2 (en) | 1979-05-18 | 1979-05-18 | Medical product packaging |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPS55151963A JPS55151963A (en) | 1980-11-26 |
| JPS5941744B2 true JPS5941744B2 (en) | 1984-10-09 |
Family
ID=13139504
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP54060346A Expired JPS5941744B2 (en) | 1979-05-18 | 1979-05-18 | Medical product packaging |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPS5941744B2 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2015046553A1 (en) | 2013-09-30 | 2015-04-02 | テルモ株式会社 | Water-absorbent carrier, method for manufacturing water-absorbent carrier, medical article, and sterilization method |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS6066747A (en) * | 1983-09-20 | 1985-04-16 | 凸版印刷株式会社 | Heat sterilization of container |
| JPS6443263A (en) * | 1987-08-10 | 1989-02-15 | Nikkiso Co Ltd | Preparation of blood purifying device |
| JPH0436838Y2 (en) * | 1988-02-09 | 1992-08-31 |
-
1979
- 1979-05-18 JP JP54060346A patent/JPS5941744B2/en not_active Expired
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2015046553A1 (en) | 2013-09-30 | 2015-04-02 | テルモ株式会社 | Water-absorbent carrier, method for manufacturing water-absorbent carrier, medical article, and sterilization method |
| US10258702B2 (en) | 2013-09-30 | 2019-04-16 | Terumo Kabushiki Kaisha | Method for manufacturing water-absorbent carrier |
Also Published As
| Publication number | Publication date |
|---|---|
| JPS55151963A (en) | 1980-11-26 |
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